The reality of the FDA's approval of the female condom
Contraceptive Technology Update 14(7): 101-106
1993
ISSN/ISBN: 0274-726X PMID: 12286995 Document Number: 330972
Many family planning experts are concerned that labeling requirements stipulated by the US Food and Drug Administration (FDA) will create an unfounded bias against the newly approved Reality female condom. Wisconsin Pharmacal Company, the US licensee of Reality, has been directed to include the message that the female condom should be used only if the male condom (claimed to be more protective against sexually transmitted diseases) cannot or will not be used. Also included on all labels, advertising, and promotion must be statistics comparing the pregnancy rates for Reality and other barrier methods. The failure rate the FDA has determined that must be cited for Reality--26%--is considered by many family planning experts to be based on dubious scientific methodology and at least 5% too high. It has been speculated that the FDA's bias against the female condom reflects a lack of confidence in women's ability to use the device correctly. Others have noted that the FDA's handling of the new condom has been based on the issue of user efficacy rather than produce safety. Wisconsin Pharmacal is in the process of distributing Reality condoms for at least half the commercial cost of US $2.50 to public sector clinics that serve women deemed to be at highest risk of human immunodeficiency virus infection.